US5014718A - Blood collection and testing method - Google Patents
Blood collection and testing method Download PDFInfo
- Publication number
- US5014718A US5014718A US07/411,083 US41108389A US5014718A US 5014718 A US5014718 A US 5014718A US 41108389 A US41108389 A US 41108389A US 5014718 A US5014718 A US 5014718A
- Authority
- US
- United States
- Prior art keywords
- skin
- blood
- vehicle liquid
- sample
- area
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
- A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
Definitions
- the present application relates to the collection and testing of cutaneous blood and blood components. More particularly, it relates to a method and apparatus for the safe, minimally-invasive, relatively painless, transcutaneous, concurrent collection of a blood sample and the testing for blood components.
- the method of the present invention comprises pretreating the external surface of an area of the skin of a human or animal to anesthetize it and to make it antiseptic; piercing the skin in on that area, without significant pain; bathing that area of the skin with a vehicle liquid; collecting a sample comprising the vehicle liquid and blood from the area on a test medium; and testing the sample for one or more diagnostic purposes.
- the method requires only a very small (about 10 microliters) amount of blood. No excess is collected, wasted or spread.
- the procedure is essentially painless and non-invasive.
- the method can include inactivating any virus that may be present in the sample.
- the apparatus of the present invention basically comprises a member having a supporting base with an upright piercing pin; a resilient, collapsible cover attached at the bottom to the base and having an open top; a porous test disk, which may contain test reagents which will react with specific substances if they are present; and a reservoir formed by the base and cover which contains a vehicle liquid which is used to transport the blood from the pierced area to the test disk.
- the preferred apparatus also includes a protective cap and seals and means for dulling nerve endings by pressure dispersal.
- FIG. 1 is a perspective view of a preferred embodiment of the apparatus of the present invention packaged prior to use.
- FIG. 2 is a sectional view taken along lines 2--2 of FIG. 1.
- FIG. 3 is a schematic view showing the apparatus being collapsed and used in the practice of the method of the present invention.
- FIG. 4 is a view showing the apparatus after the skin has been pierced, and the apparatus is no longer collapsed.
- FIGS. 1 to 4 of the drawings there is shown an embodiment of an apparatus which can be used in the practice of the method of the present invention.
- the apparatus 10 is protected prior to use by a cap 11.
- the apparatus 10 includes a supporting base 12 with an upright piercing pin 13.
- the apparatus 10 also includes a resilient, collapsible cover 14 which has a cup shaped top 15 and which is sealed at its bottom 16 to the base 12.
- the collapsible resilient, collapsible cover 14 and the base 12 form an internal reservior 17 for a vehicle liquid 18.
- the open top 15 of the cover 14 is closed by a porous test disk 19.
- the piercing pin 13 is positioned directly below the open top 15 of the cover 14 and it extends into the open month of a tubular projection 20 which depends downwardly from the cover 14.
- the apparatus 10 is normally supplied sterile with a sponge 21 containing a vehicle liquid 18 in the reservoir 17.
- the apparatus is protected from the contamination by the outer cap 11, the top seal 22 and the bottom seal 23 which are best seen in FIG. 2.
- the cap 11 and top seal 22 are first removed.
- the apparatus 10 is then placed, as seen in FIG. 3, upon an unyielding surface and the finger of the patient from whom the sample is to be collected is placed in the cup shaped top 15 of the apparatus 10.
- the skin of the finger which has been previously sterilized and anesthetized, is then pierced by pressing the finger down on the top of the apparatus 10 until the cover 14 collapses and the piercing pin 13 pierces the skin.
- the nerve endings in the area to be pierced are further dulled by the pressure dispersal; thus making the piercing relatively painless.
- the pierced skin area is bathed in vehicle liquid 18 which is forced from the sponge 21 in the reservoir 17 up the tubular projection 20 through the porous test disk 19. At the same time any air in the cupshaped top 15 is forced out.
- vehicle liquid 18 which is forced from the sponge 21 in the reservoir 17 up the tubular projection 20 through the porous test disk 19.
- any air in the cupshaped top 15 is forced out.
- the flow patterns of the vehicle liquid and the air are shown by arrows in FIG. 3.
- the finger is kept in contact with the cup shaped top 15 and the downward pressing force is relieved allowing the cover 14 to resume the uncollapsed position seen in FIGS. 2 and 4.
- the cover 14 assumes its original position a vacuum or area of reduced pressure is created in the reservoir 17 and mixture of the vehicle liquid and any blood from the pierced area are drawn back onto and through the test disk 19.
- the disk 19 contains reagents which will react with specific substances, if present, in the blood to effect a color change. The results of the tests can be read visually
- the skin is first pretreated with a solution containing anesthetic and antiseptic agent, such as Lidocaine Hydro-chloride and Benzalkonium Chloride, respectively.
- anesthetic and antiseptic agent such as Lidocaine Hydro-chloride and Benzalkonium Chloride, respectively.
- the pretreatment solution might be applied by spraying or in a gel-like binder, or with a bandage-like applicator.
- the solution could contain specific antiviral agents, or general antibacterial-antiviral-antifungal such as nonoxynol-9 (Decon Laboratories, Inc.), formalin or Betapropiolacton,, Binary ethylenediamine, and Psoralen photo chemical inactivation (Hyclone Laboratories, Inc,; Art to Science, Vol. 5, No. 3:4-5).
- the choice of chemical viral inactivator depends on which test will be made on the sample.
- the preferred vehicle liquid contains a surface active agent, such as a nonionic detergent, and an anticoagulant agent to fluidize the sample to avoid coagulation and hemolysis, such as sodium heparin and saline. It may also contain solvents such as poly-vinyl acetate, acetone and DMSO (Dimethylsulfoxide) to change the chemical nature of the sample, and analgesic and a gel or cream of high viscosity to help the cup shaped top 15 form a seal with the skin.
- the vehicle liquid can also contain other anticoagulants or chelating agents and buffering with carrier molecules to avoid nonspecific losses due to binding or deterioration and to promote preservation and inactivate virus.
- the vehicle liquid also could contain chemicals to inactivate other potential pathogens. Alternately it could enhance or grow pathogens for testing or nonpathogens as a means of detection.
- the preferred vehicle liquid contains the following ingredients:
- vasodilating compounds such as phenylephrine Hydrochloride.
- Vasodilators are preferred if more blood cells as compared to immunoglobulins are desired. Vasorestrictors can be used to prevent further bleeding at the nick.
- Triton X-100 or other surface agents providing the same function and not having any detrimental effects on the test but which will inactivate any virus that may be present can also be used.
- Representative of such surface active agents are the following: Nonidet P-40 (Shell Oil), guanidinium chloride,--mercaptoethanol or other nonionic detergents such as those listed in Stromber, K., "Surface-Active Agents for Isolation of the Core Component of Avian Myeloblastosis Virus". Journal of Virology 1972, pp. 684.697.
- the preferred anticoagulant solution contains sodium heparin.
- other anticoagulants which may be used include the following: ethylenediaminetetraacetic acid (EDTA) (0.02%), ammonium heparin, sodium citrate, streptokinase or streptodornase.
- Carrier molecules can be added to prevent nonspecific absorption of desired components or to heal the pierced area.
- anesthetic and antiseptic agents than Lidocaine (2.5% w/w), Benzalkonium Chloride (0.13% w/w) may be used.
- Other agents such as methyl salicylate (15.0%) in methanol (70% v/v), ethanol, paraben, methylparaben, providone iodine, phenol (U.5% antibiotics, dimethyl sulfoxide, acetone, polyvinyl-acetate, polyvinyl alcohol, mineral oil, propylene glycol, or polyethylene glycol can be used.
- an anti-bubble agent may be added such as Pourite (Trademark of Analytical Products, Inc., U.S. Pat. No. 4,089,748).
- a pain-depressing agent such as benzocaine or triethanolamine salicylate or a heat stimulating agent like methylsalicylate also may be included along with volatile solvents such as either. Still further the addition of mild enzyme solutions such as trypsin may be useful, depending on the blood component desired in the eluent (to inactivate degrading enzymes).
- the preferred method of piercing the skin, collecting blood components and testing comprises:
- the downward pressure exerted on the apparatus is then relieved without lifting the finger whereupon the resilient cover resumes its original state creating a vacuum which sucks the vehicle liquid 18 and any blood through and onto the test disk 19 which contains the test reagents.
- the test results are then read.
- the test reagents are on the disk 19.
- the apparatus 10 can be prepared without the test reagents being already on the test disk 19 and the reagents can be added after the collection of the blood sample.
- GLUCOSE is detected at about 5 mg/dl by a colorimetric reaction using a specific glucose-oxidase/peroxidase and guaiac chromaphore method.
- CHOLESTEROL is determined as about 100 mg/dl by a colorimetric reaction using a specific cholesterol esterasecholesterol oxidase--peroxidase and guaiac chromaphore method.
- the cholesterol test disks are made by mixing in sequence a binder of methylcellulose in water and propanol (50/50); a buffer of citric acid/sodium citrate dissolved in water, pH 6.5-7.0 with sodium taurocholate; an enzyme mixture of cholesterol esterase, cholesterol oxidase and peroxidase; and a chromogen comprised of gum guaiac in propanol.
- the mixture is applied to filter paper disks and dried to a moisture content of less than 0.2% for storage stability.
- the procedure of the present invention is minimally invasive and therefore there is less chance of secondary infection because the apparatus can be supplied presterilized and used in a sanitary manner.
- Another advantage is that the method is relatively painless.
- the vehicle liquid and blood or blood components may be obtained by the donor or another person in a one-hand operation, without technical expertise, and is essentially foolproof.
- the site of extraction is less precise than that required for phelbotomies. Therefore, a sample can be obtained more easily from infants or others with small and damaged veins or in emergency situations.
- the visual detection of test changes can be replaced by electronic detectors, if desired. For example, a hand-held colorimeter can be adapted to visualize the test disc within apparatus and the print out the test results.
- the method and apparatus of the present invention are of great potential value for use in diagnostic tests which require dilute plasma/serum for doctors/office, home health care and consumer performed diagnostics.
- An inexpensive apparatus specifically designed for a given test can be supplied completely assembled, sterile and filled with vehicle liquid by a manufacturer with the test filter in place so that all that is required is to use the device and read the results. The devices can then be disposed of without further treatment to inactivate potential virus contaminants.
- the apparatus of the present invention makes it easier to collect blood from persons who are squeamish.
- the pin which can also be a needle, is not visible at any time to the person from whom the sample is being collected.
Abstract
Description
______________________________________ COMPONENTS OF THE VEHICLE LIQUID In- Generic Name Preferred Concentration gredients Active Component Concentration Range, Active ______________________________________ Heparin Sodium 50 IU/cc 5-100 IU/cc Heparin Saline Phosphate .U5M Buffer pH 4-8 Buffered Buffered (pH 7.2) Solution Saline .45M NaCl U.2-.9M Solution NaCl (Sodium Chloride) NaCl ______________________________________
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US07/411,083 US5014718A (en) | 1988-01-22 | 1989-09-22 | Blood collection and testing method |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US14713888A | 1988-01-22 | 1988-01-22 | |
US07/411,083 US5014718A (en) | 1988-01-22 | 1989-09-22 | Blood collection and testing method |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US14713888A Continuation-In-Part | 1988-01-22 | 1988-01-22 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/540,664 Continuation-In-Part US5070886A (en) | 1988-01-22 | 1990-06-19 | Blood collection and testing means |
Publications (1)
Publication Number | Publication Date |
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US5014718A true US5014718A (en) | 1991-05-14 |
Family
ID=26844625
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US07/411,083 Expired - Fee Related US5014718A (en) | 1988-01-22 | 1989-09-22 | Blood collection and testing method |
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US (1) | US5014718A (en) |
Cited By (157)
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US5156611A (en) * | 1990-02-05 | 1992-10-20 | Becton, Dickinson And Company | Blood microsampling site preparation method |
WO1993000043A1 (en) * | 1991-06-21 | 1993-01-07 | Novo Nordisk A/S | Blood sampler |
US5201324A (en) * | 1989-03-27 | 1993-04-13 | Remi Swierczek | Disposable skin perforator and blood testing device |
US5231993A (en) * | 1991-11-20 | 1993-08-03 | Habley Medical Technology Corporation | Blood sampler and component tester with guide member |
US5304192A (en) * | 1992-01-16 | 1994-04-19 | Sherwood Medical Company | Lancet with locking cover |
US5383885A (en) * | 1993-06-29 | 1995-01-24 | Bland; Todd A. | Blood collection and testing device |
WO1996004857A1 (en) * | 1994-08-16 | 1996-02-22 | Specialized Health Products, Inc. | Multiple segment encapsulated medical lancing device |
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